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Lower risk Drug recall · FDA · Published October 31, 2024

Noven Xelstrym 13.5mg Transdermal System Recall: Defective Adhesive Risk

Noven Pharmaceuticals recalls Xelstrym 13.5mg transdermal patches due to adhesive defects. This may cause improper drug delivery. Consumers should contact Noven for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0055-2025DrugNoven Pharmaceuticals ›
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Contact the company

Recalling firmNoven Pharmaceuticals Inc11960 Sw 144th St · Miami, FL 33186-6109
✎ GovInfoNow plain-language explainer

Noven Pharmaceuticals is recalling Xelstrym (dextroamphetamine) transdermal patches because the adhesive doesn't meet quality standards. This could lead to incorrect drug delivery, but the recall doesn't specify serious injury risks. Read more at govinfonow.com/recall/32479-noven-xelstrym-13-5mg-transdermal-system-recall-defective-adhesive-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/32479-noven-xelstrym-13-5mg-transdermal-system-recall-defective-adhesive-risk · Updated September 23, 2026 · FDA enforcement record: FDA #D-0055-2025

Cite this page

“Noven Xelstrym 13.5mg Transdermal System Recall: Defective Adhesive Risk.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/32479-noven-xelstrym-13-5mg-transdermal-system-recall-defective-adhesive-risk. Based on FDA recall #D-0055-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0055-2025%22&limit=1).

Noven Pharmaceuticals Inc recalled Xelstrym transdermal patches due to a defective delivery system, the FDA said on Oct. 31, 2024. The agency announced the Class II recall of 685 boxes distributed nationwide.

How to tell if you have it

  • Brand: Noven Pharmaceuticals
  • Product: Xelstrym (dextroamphetamine) transdermal system, 13.5 mg dextroamphetamine/9 hours
  • Quantity: 30 individually sealed transdermal patches
  • NDC: 68968-0215-3
  • Lot #: 95598
  • Expiration: 02/28/25

The hazard

The product does not meet predetermined specifications for Coldflow (adhesive), according to the FDA. The recall is classified as Class II.

Context

GovInfoNow's records show Noven Pharmaceuticals Inc has 24 other recalls on record since 2011-07-05. Similar recent recalls include a defective delivery system issue for Noven Daytrana patches reported on 2023-03-10 and another adhesive defect noted on 2022-11-16. Other recent recalls of similar products include Teva Clonidine Transdermal System Recall (2026-03-19), Nivagen Zinc Oxide Ointment Recall (2025-10-31), and Bionpharma Divalproex Tablets Recall (2026-06-26).

How to tell if you have this one

Check for Xelstrym 13.5mg transdermal patches with NDC 68968-0215-3, manufactured in Miami, FL, Lot # 95598, expiring 02/28/25.

  • Brand
    Noven Pharmaceuticals
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Contact Noven

    Reach out to Noven Pharmaceuticals for specific instructions on handling the recalled product.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “USA nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 27 days after the firm started it.

1. Firm started the recall: Oct 31, 202412. FDA classified it Class II: Nov 19, 202423. Published in FDA’s Enforcement Report: Nov 27, 202432024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Keep exploring

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-0055-2025 (October 31, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0055-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on September 23, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA